Kevzara

Medicinal product

(Invented) name

Kevzara

Active substance (s)

Sarilumabas

Strength

150 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AC14, Sarilumab

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2017-06-23

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled pen	1.14 ml
Sarilumabas	150 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
68622	83204	1083204	užpildytas švirkštiklis	N2		Receptinis	EU/1/17/1196/005	Netiekiama	-	-	No	-	-
68623	83205	1083205	užpildytas švirkštiklis	N6 (3x2)		Receptinis	EU/1/17/1196/006	Netiekiama	-	-	No	-	-
98475	84578	1084578	užpildytas švirkštiklis	N1		Receptinis	EU/1/17/1196/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-23	Registruotas